Evaluating the Potential of Virtual Reality in Alleviating Pain and Anxiety Among Thalassemia Patients During Intravenous Cannulation: A Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Assessment of Anxiety using the Visual Analogue Scale
研究概览
简要总结
The goal of this trial is to evaluate the effects of therapeutic Virtual Reality (VR) on pain, anxiety, fatigue and boredom during intravenous (IV) cannulations in comparison to standard of care (SOC).The main question it aims to answer is whether VR can act as an adjuvant for the IV cannulation procedure and improve overall patient experience.
Questionnaires were completed after the intravenous cannulation procedure during visits 1, 2 and 3. The Visual Analogue Scale (VAS) was used to assess both primary (pain and anxiety) and secondary (fatigue and boredom) objectives, collecting self-reported data during the three visits.
Heart Rate (measured in beats per minute (BPM)) and Blood Pressure (measured in millimeters of mercury (mmHg)) were measured after each procedure
- Participants will come for their routine cannulation and be recruited if willing
- Participants carry out the SOC procedure and are asked to fill out the questionnaires after
- The procedure is carried out with VR at the next appointment after 3-4 weeks
- This is repeated in the next visit
详细描述
Patients were screened at the Dubai Thalassemia Center during routine consultations, where the investigator present explained the study's objectives to the patient.
After consulting the patients' medical records and ensuring that there were no exclusion criteria and that the inclusion criteria were met, the investigators introduced themselves to the patients and their families, offering them the chance to take part in the study.
The investigators then explained to patients that they were eligible for this study and described the study's aims. Written, signed consent was obtained from adult patients and guardians of minors with an informed consent form.
Additionally, patients aged <18 years were provided with an assent form with simplified information about the study. Investigators took the time to answer the patient's questions about the study's progress, expected results, and anticipated benefits.
No financial compensation was paid to participants in this study. Participation in this study had no financial consequences for the participant, nor on his/her health insurance, as this was part of the routine care and consultation for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of thalassemia
- •Thalassemia patients undergoing intravenous cannulation procedure
- •Patients aged >7 years (male, female, adult, pediatrics, national and non-national) at the Dubai Thalassemia Center
排除标准
- •Pregnant or nursing women
- •Patients of legal age but subject to legal protection measures or unable to express their consent
- •Patients suffering from uncontrolled epilepsy
- •Patients with visual or auditory disorders
- •Patients suffering from claustrophobia or motion sickness
- •Patients with face infections
- •Patients with dissociative psychiatric pathologies and/or autism
结局指标
主要结局
Assessment of Anxiety using the Visual Analogue Scale
时间窗: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, Zero is equivalent to no anxiety and 10 indicates the worst possible anxiety.
Assessment of Pain using the Visual Analogue Scale
时间窗: During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.
Self-reported data assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, 0 is equivalent to no pain and 10 indicates the worst possible pain.
次要结局
- Assessment of Boredom using the Visual Analogue Scale(During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.)
- Heart Rate (BPM)(After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.)
- Assessment of Fatigue using the Visual Analogue Scale(During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.)
- Assessment of Patient Satisfaction(During the length of the cannulation procedure/VR session (between 10-20 minutes), at each clinical visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.)
- Blood Pressure (mmHg)(After the cannulation procedure, at each clinic visit. Participants were scheduled for their next clinical visit/cannulation procedure exactly 2-4 weeks later, based on cross-matching results.)
研究者
Sameer Asim Khan
MD Student
Mohammed Bin Rashid University of Medicine and Health Sciences